Improving Informed Consent for English and Spanish Speakers in Clinical Trials [0.03%]
改善临床试验中英语和西班牙语受试者的知情同意书
Susana Peinado,Jessica E Thompson,Leo Plouffe et al.
Susana Peinado et al.
Background: Patients often have suboptimal understanding of informed consent in clinical trials, impeding their ability to make informed decisions about participation. Additionally, translating complex informed consent in...
Regulatory Performance of African National Medicines Regulatory Authorities Achieving WHO Maturity Level 3: Identifying Best Practices [0.03%]
达到世界卫生组织成熟度第三级别的非洲国家药品监管机构的表现：识别最佳实践
Mercy Owusu-Asante,Delese Mimi Darko,Boitumelo Semete-Makokotieia et al.
Mercy Owusu-Asante et al.
Background: The World Health Organization (WHO) developed the WHO Global Benchmarking Tool (GBT) to assess and benchmark the drug regulatory systems and practices in national medicines regulatory authorities (NMRAs). The ...
Hurry Up and Wait: Timelines and Takeaways from the Biomarker Qualification Program [0.03%]
加快进度，耐心等待——生物标志物资格认证计划的启示及感悟
Grace Collins,Jeff D Allen,Hillary S Andrews et al.
Grace Collins et al.
Background: The Biomarker Qualification Program (BQP), formally established in 2016 under the 21st Century Cures Act, is a key pathway for developing novel biomarkers for regulatory use. We evaluated eight years of BQP ex...
Strategic Drivers Behind Early Withdrawal of Orphan Designations in the EU: A Retrospective Analysis (2000-2024) [0.03%]
欧盟孤儿药资格早期撤回的战略驱动因素：2000-2024年回顾性分析
Luísa Bouwman,Micael Castanheira,Georges Siotis
Luísa Bouwman
Purpose: The orphan legislation came into force in the European Union (EU) in 2000, providing incentives for the development of orphan medicines. To be eligible for incentives, the applicant needs to apply for an orphan d...
Risk of Venous Thromboembolism with Pemafibrate in Dyslipidemia: A Nationwide, Retrospective, Cohort Study Using a Japanese Claims Database [0.03%]
贝迈孚瑞治疗血脂异常的静脉血栓栓塞风险：一项日本全国范围回顾性队列研究
Kenichiro Ikeda,Mika Tada,Shun Nakano et al.
Kenichiro Ikeda et al.
Aims: The study aimed to assess whether pemafibrate, a selective peroxisome proliferator-activated receptor α modulator, increases the risk of venous thromboembolism (VTE) in real-world clinical practice in Japan. ...
Estimating Treatment Effect for Target Population in Psychiatric Clinical Trials Using Placebo Lead-in Design [0.03%]
利用安慰剂导入设计估计精神病临床试验受试人群的处理效应
Zhao Yang
Zhao Yang
The placebo lead-in design is commonly utilized in psychiatric clinical trials to mitigate high placebo response rates; conventional methods for estimating treatment effects typically rely solely on data from the second period, disregarding...
Quality of Reports on Drug Toxicity in Eudravigilance: A Safety Physician's Perspective [0.03%]
欧洲药品 Vigilance 中关于药物毒性报告的质量：安全医师的视角
Jana Brajdih Čendak
Jana Brajdih Čendak
Background: European legislation requires Marketing Authorization Holders (MAHs) to continuously monitor Eudravigilance (EV) data and inform the European Medicines Agency and national competent authorities of validated sa...
Beyond REMS & PDMPs: A Proposed Framework for Next-Generation Opioid Regulation [0.03%]
从REMS和PDMPs出发：下一代阿片类药物监管框架之构想
Aysha Rana,Kavetha Ram
Aysha Rana
This paper proposes a next-generation regulatory framework for opioid analgesics that integrates real-world data, adaptive licensing and labelling, and community-driven surveillance to overcome the shortcomings of traditional, static regula...
Regulatory Experiences with the Use of Multiple Imputation for Missing Data in a Phase 3 Confirmatory Trial [0.03%]
监管机构关于在III期确证性试验中使用多重填补处理缺失数据的经验
Mouna Sassi-Sayadi,Pierre Verweij,Peter Cornelisse
Mouna Sassi-Sayadi
The Mixed Model for Repeated Measures (MMRM) is widely used in clinical trials, however, its reliance on the Missing at Random (MAR) assumption and the exclusion of subjects lacking post-baseline data have been points of scrutiny, particula...
Trends in FDA Data Integrity Enforcement Before and After the COVID-19 Pandemic: An Analysis of 1766 Warning Letters (2016-2023) [0.03%]
FDA数据完整性的执法趋势：对2016年至2023年1766封警告信的分析（新冠疫情前后）
Yoseok Park,Kyenghee Kwon
Yoseok Park
Background: Data integrity (DI) has become a cornerstone of regulatory oversight in pharmaceutical manufacturing. The COVID-19 pandemic coincided with increased digitalization and wider use of remote inspection approaches...